FDA approves Gazyva for previously untreated follicular lymphoma

CancerConnect News: The United States Food and Drug Administration granted regular approval to Gazyva (obinutuzumab) in combination with chemotherapy, followed by Gazyva monotherapy in patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II bulky, III, or IV follicular lymphoma (FL).1 As previously reported, Gazyva was found to be superior to Rituxan (rituximab) in the treatment of selected patients with FL.2

About Follicular Lymphoma

Follicular lymphoma is the most common indolent (slow-growing) form of non-Hodgkin’s lymphoma (NHL), accounting for about one in five cases of NHL. It is considered incurable and relapse is common. In the United States, it is estimated that more than 14,000 new cases of follicular lymphoma will be diagnosed in 2017.

About Gazyva

Gazyva is an engineered monoclonal antibody designed to attach to CD20, a protein found on certain types of B-cells. It is thought to work by attacking targeted cells both directly and together with the body’s immune system.

Approval was based on a multicenter, open-label, randomized phase 3 trial (GALLIUM) for patients with previously untreated non-Hodgkin lymphoma, including 1202 patients with FL. Patients were randomized 1:1 to receive either Gazyva + chemotherapy or Rituxan + chemotherapy, followed in responding patients by Gazyva or Rituxan maintenance for up to 2 years. Of the patients with FL, 91% had stage III-IV disease, 44% had bulky disease, and 79% had at least intermediate-risk disease. The chemotherapy backbone was Treanda® (bendamustine) in 57%, CHOP in 33% and CVP in 10%. With a median follow-up of 38 months, progression-free survival, as assessed by an independent review committee, was statistically significantly improved in the Gazyva arm compared to the Rituxan arm. Median progression-free survival was not reached in either arm. As assessed by CT, the arms had similar overall response rates (91% with Gazyva, 88% with Rituxan) and complete remission rates (28% and 27%, respectively).

Among the 1385 patients evaluated for safety, the Gazyva arm had higher incidences of serious adverse reactions (ARs; 50% compared to 43% in the Rituxan arm), grade ≥ 3 ARs (79% vs. 72%) and fatal infections (2% vs. < 1%). The most common ARs in the Gazyva arm (incidence ≥ 20% and ≥ 2% greater than in the Rituxan arm) included infusion reactions, neutropenia, upper respiratory tract infection, cough, constipation and diarrhea. The most common grade ≥ 3 ARs (incidence ≥ 5%) observed more frequently with Gazyva were neutropenia, febrile neutropenia, thrombocytopenia and infusion reactions. Recipients of Treanda® had higher incidences of serious and fatal infections than recipients of CHOP or CVP.